Pregnant WomenPhase 3NCT06775431
Comparing Prophylactic Intravenous Pethidine and Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
A Phase 3 study testing Pethidine Hydrochloride 50 Mg/mL Solution for Injection and Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally in people with Pregnant Women, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering in females undergoing caesarean section. The main question it aims to answer is: which route is more efficacious in preventing shivering. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Pethidine Hydrochloride 50 Mg/mL Solution for Injection and Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2024to Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- -
Who cannot join
- contraindications to spinal
- uncontrolled hypertension, diabetes mellitus, hepatic, pulmonary diseases, and thyroid disease
- obesity (BMI >35)
- drug allergy
- temperature below 36 degrees celcius or above 37.5 degrees celcius
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
El-Shatby University Hospital
Alexandria, Alexandria Governorate
Shahira El Metainy, Professor of Anesthesia, 00201227498438, shahira.almteni@alexmed.edu.eg
Moutaz A Ghandour, Lecturer of Anesthesia
About this study
Official title: Comparison of Prophylactic Intravenous Pethidine Versus Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
The goal of this clinical trial is to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering in females undergoing caesarean section. The main question it aims to answer is: which route is more efficacious in preventing shivering.
Researchers will compare IV pethidine and intrathecal pethidine to see their effects on post spinal shivering, their effects on hemodynamic stability, nausea, vomiting, and sedation.
Read the detailed description
This study will be a single blinded, randomized, prospective controlled study. After obtaining written informed consents, 86 patients of American Society of Anesthesiologists physical status II, aged 20-40 years old, undergoing spinal anesthesia for elective cesarean section will be investigated at El-Shatby University Hospital.
The patients will be randomized into two groups of n=43 each using a computer-generated sequence. Allocation concealment will be done using sealed envelope technique. Depending on the group allocation either to receive IV Pethidine 0.5mg/kg (Group A n=43 patients) as premedication mixed into 10 ml isotonic saline slowly IV or intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% (Group B n=43 patients). SA will be given at either L3-L4 or L4-L5 in the sitting position by the anesthetist using 22-25-gauge Quincke spinal needles. Patients will be covered with drapes but not actively warmed. 10mg ephedrine will be given if the patient becomes hypotensive (hypotension is defined as a decrease in MAP of >20% from the baseline). 0.5 mg atropine IV will be given if HR less than 50 beats/min. Rescue 4 mg ondansetron IV will be given for vomiting episodes. Room temperature will be maintained about 21 - 24ºC during the perioperative period in the OR and in the PACU, using temperature control system. The presence of shivering will be observed and graded after spinal injection by using Tsai and Chu Scale.
The following parameters will be measured:
- Vital signs (heart rate, and blood pressure) will be measured at baseline and every 5 minutes after administration of the drug for 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes in the first two hours postoperatively
- Body temperature (in degrees Celsius), will be measured, using axillary thermometer before drug administration then every 15 minutes till the end of surgery. After surgery, axillary temperature will be measured every 30 minutes for 2 hours.
- Using Tsai and Chu Scale for shivering assessment, the incidence, duration, time interval from onset of spinal block to shivering occurrence, and intensity of shivering will be recorded every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively in the recovery room.
- Complications of the drugs, such as nausea, vomiting and sedation will be recorded.
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering. The secondary aims will be to assess the effect of different routes of administration of the drug on hemodynamic stability, nausea, vomiting, and sedation.
- Conditions
- Pregnant Women
- Being tested
- Pethidine Hydrochloride 50 Mg/mL Solution for Injection, Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally
- Keywords
- post spinal shivering, IV pethidine, intrathecal pethidine, caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pethidine Hydrochloride 50 Mg/mL Solution for InjectionDrug
Pethidine will be administered intravenously in group A 0.5 mg/kg as premedication
Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecallyDrug
0.2 mg/kg pethidine in trathecally will be administered with bupivacaine 0.5% in group B
| Study group | Role | What they receive |
|---|---|---|
| IVGroup | Active comparator | This group will receive IV 0.5mg/kg Pethidine as premedication mixed into 10 ml normal saline slowly IV Receives: Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection |
| Intrathecal Group | Active comparator | This group will receive intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% Receives: Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering incidence
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence of shivering
Measured: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
Onset of shivering
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the onset of shivering
Measured: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
Duration of shivering
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the duration of shivering
Measured: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
Shivering intensity
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the intensity of shivering, using the Tsai and Chu Scale
The intensity of shivering using Tsai and Chu scale is measured as follows:
0: no shivering
- piloerection or peripheral vasoconstriction, but no visible shivering
- muscular activity in only one muscle group
- muscular activity in more than one muscle group, but not generalized
- shivering involving the whole body
Measured: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
Secondary outcomes (3)
Hemodynamic stability
The secondary outcome is to assess the effect of different routes of administration of the drug on hemodynamic stability, by measuring the heart rate and blood pressure
Measured: at baseline and every 5 minutes after administration of the drug for 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes in the first 2 hours postoperatively
Incidence of vomiting
The secondary outcome is to assess the effect of different routes of administration of the drug on incidence of vomiting
Measured: from administration of spinal till 2 hours postoperatively
Incidence of sedation
The secondary outcome is to assess the effect of different routes of administration of the drug on incidence of sedation
Measured: from administration of spinal till 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start10 Dec 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775431
- Sponsor's protocol ID
- 0306931
- Status last verified
- Oct 2024
- First submitted
- 4 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prophylactic Intravenous Pethidine Versus Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
- ClinicalTrials.gov ID
- NCT06775431
- Acronym / sponsor ID
- 0306931
- Conditions
- Pregnant Women
- Keywords
- post spinal shivering, IV pethidine, intrathecal pethidine, caesarean section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering in females undergoing caesarean section. The main question it aims to answer is: which route is more efficacious in preventing shivering.
Researchers will compare IV pethidine and intrathecal pethidine to see their effects on post spinal shivering, their effects on hemodynamic stability, nausea, vomiting, and sedation.
Detailed description
This study will be a single blinded, randomized, prospective controlled study. After obtaining written informed consents, 86 patients of American Society of Anesthesiologists physical status II, aged 20-40 years old, undergoing spinal anesthesia for elective cesarean section will be investigated at El-Shatby University Hospital.
The patients will be randomized into two groups of n=43 each using a computer-generated sequence. Allocation concealment will be done using sealed envelope technique. Depending on the group allocation either to receive IV Pethidine 0.5mg/kg (Group A n=43 patients) as premedication mixed into 10 ml isotonic saline slowly IV or intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% (Group B n=43 patients). SA will be given at either L3-L4 or L4-L5 in the sitting position by the anesthetist using 22-25-gauge Quincke spinal needles. Patients will be covered with drapes but not actively warmed. 10mg ephedrine will be given if the patient becomes hypotensive (hypotension is defined as a decrease in MAP of >20% from the baseline). 0.5 mg atropine IV will be given if HR less than 50 beats/min. Rescue 4 mg ondansetron IV will be given for vomiting episodes. Room temperature will be maintained about 21 - 24ºC during the perioperative period in the OR and in the PACU, using temperature control system. The presence of shivering will be observed and graded after spinal injection by using Tsai and Chu Scale.
The following parameters will be measured:
- Vital signs (heart rate, and blood pressure) will be measured at baseline and every 5 minutes after administration of the drug for 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes in the first two hours postoperatively
- Body temperature (in degrees Celsius), will be measured, using axillary thermometer before drug administration then every 15 minutes till the end of surgery. After surgery, axillary temperature will be measured every 30 minutes for 2 hours.
- Using Tsai and Chu Scale for shivering assessment, the incidence, duration, time interval from onset of spinal block to shivering occurrence, and intensity of shivering will be recorded every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively in the recovery room.
- Complications of the drugs, such as nausea, vomiting and sedation will be recorded.
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering. The secondary aims will be to assess the effect of different routes of administration of the drug on hemodynamic stability, nausea, vomiting, and sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVGroup | Active comparator | Drug: Pethidine Hydrochloride 50 Mg/mL Solution for InjectionThis group will receive IV 0.5mg/kg Pethidine as premedication mixed into 10 ml normal saline slowly IV |
| Intrathecal Group | Active comparator | Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecallyThis group will receive intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (5 listed)
- contraindications to spinal
- uncontrolled hypertension, diabetes mellitus, hepatic, pulmonary diseases, and thyroid disease
- obesity (BMI >35)
- drug allergy
- temperature below 36 degrees celcius or above 37.5 degrees celcius
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pethidine Hydrochloride 50 Mg/mL Solution for InjectionPethidine will be administered intravenously in group A 0.5 mg/kg as premedication | Drug | IVGroup |
| Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally0.2 mg/kg pethidine in trathecally will be administered with bupivacaine 0.5% in group B | Drug | Intrathecal Group |
Primary outcome
Shivering incidence
Time frame: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence of shivering
Onset of shivering
Time frame: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the onset of shivering
Duration of shivering
Time frame: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the duration of shivering
Shivering intensity
Time frame: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the intensity of shivering, using the Tsai and Chu Scale The intensity of shivering using Tsai and Chu scale is measured as follows: 0: no shivering 1. piloerection or peripheral vasoconstriction, but no visible shivering 2. muscular activity in only one muscle group 3. muscular activity in more than one muscle group, but not generalized 4. shivering involving the whole body
3 secondary outcomes
Hemodynamic stability
Time frame: at baseline and every 5 minutes after administration of the drug for 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes in the first 2 hours postoperatively
Incidence of vomiting
Time frame: from administration of spinal till 2 hours postoperatively
Incidence of sedation
Time frame: from administration of spinal till 2 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
Related trials for Pregnant Women
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pethidine Hydrochloride 50 Mg/mL Solution for Injection and Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally in people with Pregnant Women, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai A El-Sayed, Lecturer of Anesthesia (00201287459922, m_mohamed165@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shivering incidence (time frame: every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.